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Inebilizumab

Clinical trials are investigating Inebilizumab in several diseases, including anti-NMDAR encephalitis, NMOSD, myasthenia gravis, and IgG4-related disease. These studies look at safety, effectiveness, and how the treatment behaves in adults and children. Some trials compare Inebilizumab with placebo, while others are open-label studies.

Table of Contents

Trial overview

The clinical trials in this set study Inebilizumab in people with different immune-related diseases.[1] The trials are looking at whether the treatment can improve disease control, reduce disability, or lower the risk of flare-ups, while also checking safety and tolerability.[1][2][3][4][5][6]

Conditions being studied

One Phase 2 trial studies anti-N-methyl-D-aspartate receptor encephalitis, also called anti-NMDAR encephalitis, in which the main goal is to compare disability after treatment with Inebilizumab versus placebo.[1]

Another Phase 2 trial studies neuromyelitis optica spectrum disorder, also called NMOSD, in children and adolescents.[2] The trial title also notes older names for this condition, including Devic’s syndrome and neuromyelitis optica (NMO).[2]

Two trials study myasthenia gravis: one in adults with AChR-Ab+ or MuSK-Ab+ disease, and one in children with generalized myasthenia gravis (gMG).[3][6] Two trials study IgG4-related disease, one in adults and one in pediatric participants.[4][5]

Study designs and phases

The trials are split between Phase 2 and Phase 3 studies.[1][2][3][4][5][6]

The Phase 3 studies are in adults with myasthenia gravis and IgG4-related disease, and both are designed to test whether Inebilizumab works better than control treatment in larger groups.[3][4] The anti-NMDAR encephalitis and adult IgG4-related disease trials are randomized and placebo-controlled, meaning participants are assigned by chance and some receive placebo for comparison.[1][4]

The pediatric NMOSD, pediatric IgG4-related disease, and pediatric gMG studies are open-label or uncontrolled, which means everyone in the study receives the study treatment and there is no placebo group in the trial description.[2][5][6]

Who can take part

These studies include different age groups and diagnoses, so eligibility depends on the trial.[1][2][3][4][5][6]

  • Adults with myasthenia gravis due to AChR antibodies or MuSK antibodies are included in one Phase 3 trial.[3]
  • Children and adolescents with NMOSD are included in one Phase 2 trial.[2]
  • Adults with IgG4-related disease are included in one Phase 3 trial.[4]
  • Children with IgG4-related disease are included in one Phase 2 trial.[5]
  • Children with generalized myasthenia gravis are included in one Phase 2 trial.[6]
  • Patients with anti-NMDAR encephalitis are included in one Phase 2 trial that measures disability and safety over time.[1]

Main outcomes being measured

The main outcome in the anti-NMDAR encephalitis study is the change in mRS at 16 weeks, which is a scale used to measure disability and daily function.[1] That trial also measures safety by counting treatment-emergent adverse events and serious adverse events up to 24 weeks.[1]

In the adult myasthenia gravis trial, the main outcome is the change from baseline in MG-ADL score at Week 26 in the full study population, including both AChR-Ab+ and MuSK-Ab+ participants.[3] MG-ADL is a daily living score that reflects how much the disease affects common activities.[3]

The adult IgG4-related disease trial measures time to disease flare over a 52-week period.[4] A flare means the disease gets worse and needs new or stronger treatment, such as glucocorticoids, other immunotherapy, or a procedure.[4]

The pediatric NMOSD, pediatric IgG4-related disease, and pediatric gMG studies all include pharmacokinetic measures, B-cell counts, and safety outcomes such as adverse events, serious adverse events, laboratory changes, and vital signs.[2][5][6]

Key trial details

  • NCT04372615 is a Phase 2 trial in anti-NMDAR encephalitis with 116 participants and a placebo-controlled design.[1] It compares disability at 16 weeks and tracks safety through 24 weeks.[1]
  • NCT05549258 is a Phase 2 pediatric trial in NMOSD with 15 participants.[2] It focuses on pharmacokinetics, B-cell counts, and safety.[2]
  • NCT04524273 is a Phase 3 adult myasthenia gravis trial with 230 participants.[3] It measures change in MG-ADL at Week 26.[3]
  • NCT04540497 is a Phase 3 adult IgG4-related disease trial with 200 participants.[4] It measures time to disease flare over 52 weeks and uses a placebo control.[4]
  • NCT07222553 is a Phase 2 pediatric IgG4-related disease trial with 15 participants.[5] It studies pharmacokinetics, B-cell counts, and safety.[5]
  • NCT06987539 is a Phase 2 pediatric generalized myasthenia gravis trial with 12 participants.[6] It also measures pharmacokinetics, B-cell counts, and safety.[6]
Trial ID Phase Condition studied Status Enrollment
NCT04372615 Phase 2 Anti-NMDAR encephalitis Authorised 116
NCT05549258 Phase 2 NMOSD in children and adolescents Authorised 15
NCT04524273 Phase 3 Myasthenia gravis (AChR-Ab+ or MuSK-Ab+) Authorised 230
NCT04540497 Phase 3 IgG4-related disease Authorised 200
NCT07222553 Phase 2 IgG4-related disease in children Authorised 15
NCT06987539 Phase 2 Generalized myasthenia gravis in children Authorised 12

FAQ

  • What conditions are being studied with Inebilizumab? The trials in this data study anti-NMDAR encephalitis, neuromyelitis optica spectrum disorder (NMOSD), myasthenia gravis, and IgG4-related disease. Some studies focus on adults, while others focus on children and adolescents.
  • What phases are the Inebilizumab trials in? The trials are in Phase 2 and Phase 3. Phase 2 studies often look at early signs of benefit, safety, and how the drug behaves in the body, while Phase 3 studies compare treatment effects in larger groups.
  • Who can take part in these trials? Eligibility depends on the disease being studied and the age group. The trials include adults with myasthenia gravis and IgG4-related disease, as well as pediatric participants with NMOSD, IgG4-related disease, and generalized myasthenia gravis.
  • What are the main goals of these studies? The studies aim to measure outcomes such as disability, disease flare, safety, tolerability, and changes in B-cell counts. Some trials also measure pharmacokinetics, which means how the treatment moves through the body over time.
  • Are any of the trials placebo-controlled? Yes. The anti-NMDAR encephalitis trial and the IgG4-related disease Phase 3 trial are placebo-controlled. This means some participants receive Inebilizumab and others receive placebo, which looks the same but has no active treatment.

Ongoing Clinical Trials on Inebilizumab

  • A study testing how inebilizumab works and how safe it is in children and teenagers aged 2 to 17 years with generalized myasthenia gravis

    Recruiting

    1 1 1
    Investigated drugs:
    France Italy Poland Spain

  • A study to evaluate the safety and effects of inebilizumab in children and adolescents with immunoglobulin G4-related disease

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Greece Italy Poland Spain

  • Study of Inebilizumab for Children and Adolescents with Neuromyelitis Optica Spectrum Disorder

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France The Netherlands Poland Spain Sweden

  • Study on the Effects and Safety of Inebilizumab for Patients with Anti-NMDA Receptor Encephalitis

    Recruiting

    1 1
    Investigated drugs:
    The Netherlands Spain

  • Study on the Effectiveness of Inebilizumab for Patients with IgG4-Related Disease

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland Spain

  • Study on the Effects of Inebilizumab for Adults with Myasthenia Gravis

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

Glossary

  • Anti-NMDAR encephalitis: A brain inflammation condition linked to antibodies against NMDA receptors. It can cause problems with thinking, behavior, movement, and seizures.
  • Neuromyelitis optica spectrum disorder (NMOSD): A rare disease that affects the optic nerves and spinal cord. It can lead to vision loss, weakness, and other nerve-related symptoms.
  • Myasthenia gravis: A disease that causes muscle weakness because the immune system attacks parts of the connection between nerves and muscles.
  • IgG4-related disease (IgG4-RD): An immune-related disease that can affect different organs and cause inflammation and damage.
  • Placebo: A treatment that looks like the study drug but does not contain active medicine. It is used to compare results fairly.
  • Phase 2: A mid-stage clinical trial that usually studies safety and early signs of benefit in a smaller group of people.
  • Phase 3: A later-stage clinical trial that studies whether a treatment works well and is safe in a larger group of people.
  • Pharmacokinetics (PK): How the body absorbs, moves, and removes a treatment over time.
  • Pharmacodynamics (PD): What the treatment does in the body, such as changes in cells or other body markers.
  • CD20-positive B cells: A type of immune cell measured in some trials to see how the treatment affects the immune system.
  • Disease flare: A worsening of disease symptoms that may need extra treatment.
  • mRS: The modified Rankin Scale, a score used to measure disability and how much help a person needs in daily life.

References